Clinical trial

National, Multicentre, Randomized, Double-blind, Double-dummy Phase II Clinical Trial to Evaluate the Efficacy and Safety of S (+) - Ibuprofen for Pain Control in Individuals With Osteoarthritis

Name

APS003/2020

Description

The purpose of this study is to evaluate the efficacy of S (+) - ibuprofen compared to an active treatment for pain control in individuals diagnosed with osteoarthritis.

Trial arms

Trial start

2022-08-05

Estimated PCD

2023-06-30

Trial end

2023-06-30

Status

Completed

Phase

Early phase I

Treatment

S (+) - Ibuprofen

S (+) - Ibuprofen + placebo of Ibuvix®

Arms:

S (+) - Ibuprofen

Ibuvix® - ibuprofen

Ibuvix® + placebo of S(+) - Ibuprofen

Arms:

Ibuvix® - ibuprofen

Size

176

Primary endpoint

Mean reduction of pain measured by the WOMAC Osteoarthritis Index (pain)

Baseline (day 0) and Week 4 (day 28)

Eligibility criteria

Main Inclusion Criteria: * Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * Patients aged from 18 to 75 with a diagnosis of knee and/or hip osteoarthritis according to American College of Rheumatology (ACR) criteria. Main Exclusion Criteria: * Known hypersensitivity to the formula components used during the clinical trial; * Previous history of alcohol or drugs abuse diagnosed by DSM-V; * Current or previous history (less than 12 months) of smoking; * Have clinically relevant abnormal laboratory results according to medical evaluation; * Women who are pregnant, lactating, or positive for β - hCG urine test;

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 176, 'type': 'ACTUAL'}}

Updated at

2023-07-17

1 organization

2 products

1 indication

Organization

Product

Indication

Product